Drug Substance - Process Development

BioDuro-Sundia is your partner for accelerating drug discovery, development and manufacturing--from molecule to market. Find out more at http://www.bioduro-sundia.com. 

BioDuro-Sundia provides clinical development and commercial manufacturing of drug product—specializing in oral solid dosage forms and poorly soluble APIs. Our drug product services platform combines comprehensive pre-formulation assessment with advanced formulation technologies and robust GMP manufacturing capability.

BioDuro-Sundia’s Drug Substance manufacturing services support production of small molecule APIs, RSMs and intermediates--both GMP and non-GMP .  We provide a full range of production scale, supporting all stages of drug substance development through IND submission.

BioDuro-Sundia’s Solubility Enhancement service is the fastest & most effective path to clinical formulation. We combine computer modeling, in-vitro screening & in-vivo PK to deliver optimal Amorphous Solid Dispersion prototypes. With 50-100mg of API & 8-10 weeks, we provide reliable prototypes to use in Phase I formulation & dosage development.

BioDuro’s analytical team is well-integrated into the formulation and manufacturing programs to facilitate and accelerate the development of the analytical methods and testing of prototypes, raw materials and drug products. Sharing knowledge of the formulation and the manufacturing process results in analytical data that is scientifically sound and project support that is well-coordinated and timely.

Experienced and dedicated development and QC chemists at BioDuro are committed to the highest levels of technical quality and GMP compliance.

BioDuro-Sundia's Drug Product manufacturing services support clinical and commercial scale GMP production for a comprehensive range of oral solid dosage forms, including: solid, liquid, and semi solid dosage forms. This includes fully-audited manufacturing facilities (FDA and other regulators) with exceptional track records.  Our manufacturing teams work closely with our formulation development teams to ensure optimal drug delivery from all dosage forms, especially poor solubility APIs.

BioDuro-Sundia holds more than 25 years of experience formulating poor solubility and  poor permeability drugs for the clinical studies. Our comprehensive suite of advanced formulation technologies and extensive scientific know-how supports >95% of marketed dosage forms.  Our GMP manufacturing operations focus on quality, efficiency and reliability ensures timeliness for your clinical trial supply. 

Bioavailability enhancement for poorly soluble compounds

BioDuro-Sundia offers Discovery Chemistry services provide small molecule design and synthesis to guide your drug discovery program through hit generation, SAR, lead optimization and candidate selection. We leverage decades of cutting edge expertise in medicinal, synthetic, and computational chemistry.

BioDuro-Sundia’s Discovery Biology team has extensive experience in assay development and compound screening using biochemical and cell-based phenotypic functional assays for all major classes of drug targets, including: enzymes, GPCRs, epigenetics, PROTACs and beyond.

BioDuro-Sundia's Drug Metabolism and Pharmacokinetic (DMPK) services provide high quality in vitro and in vivo studies to help predict therapeutic outcomes and advance programs toward the clinic. We integrate with our early formulation development team to prepare for the clinic and maximize likelihood of successful development.

Since 2015 the field of targeted protein degradation has rapidly emerged, offering opportunities for novel pharmacological interventions in ways impossible to achieve with traditional small molecule inhibitors. This webinar focuses on cutting-edge drug discovery using protein degraders, such as PROTACS, in diverse therapeutic areas. Attendees can expect to learn about recent strategies toward development of orally bioavailable protein degrader drug candidates—PROTACs and beyond.